Rheumatoid Arthritis Clinical Trial
| NCT number | NCT02371096 |
| Other study ID # | RGB-03-104 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | Phase 1 |
| First received | February 5, 2015 |
| Last updated | February 19, 2015 |
| Verified date | February 2015 |
| Source | Gedeon Richter Plc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.
| Status | Not yet recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Active Rheumatoid Arthritis - Inadequate response or intolerance to other DMARDs and anti-TNFs - Treatment with Methotrexate Exclusion Criteria: - Previous treatment with rituximab - Patients with systemic manifestations of rheumatoid arthritis - Patients seropositive for HIV, HCV, HBV - Female patients nursing Other protocol-defined inclusion/exclusion criteria may apply. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Gedeon Richter Plc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area under the serum concentration versus time curve (AUC) | 0-24 weeks |
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